Breast Cancer, Chemo-brain, Impaired Cognition
Conditions
Keywords
Chemotherapy related cognitive impairment, Chemo-brain
Brief summary
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
Detailed description
* This study is being done to study effects of chemotherapy (cancer treatment) on the brain and cognition (thinking). "Chemo-brain" is a term sometimes used to refer to effects of chemotherapy on the brain and cognition (thinking). * This study is being done to test for "chemo-brain" in older adults with breast cancer treated with chemotherapy, and to identify people who are most likely to be affected. The investigators will look at thinking abilities and brain images before and after chemotherapy to see if it can help identify people at risk for cognitive side effects of the treatment, and to better understand effects of treatment on brain structure and function. * The investigators are looking for participants who have either been recently recently diagnosed breast cancer participant or a healthy volunteer. * What is involved in the study: * Memory and Thinking Tests * Imaging: Either MRI/or MRI and PET Scans
Interventions
OTHERCognitive, functional and subjective assessments
Cognitive and functional assessments
DEVICEMRI
Magnetic Resonance Imaging (MRI) Scan
RADIATIONPET Scan
Positron Emission Tomography (PET) Scan
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Breast cancer patients treated with chemotherapy- Group 1 (experimental group) * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study * New diagnosis histologically confirmed invasive breast cancer * Treatment plan to include chemotherapy * Female subjects age ≥ 60 years. * Life expectancy ≥ 1 year * Karnofsky Performance Score (KPS) ≥ 80 * Ability to understand and the willingness to sign a written informed consent document. * Non-treated breast cancer patient controls- Group 2 (control group) * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study: * New diagnosis histologically confirmed invasive breast cancer * Treatment plan does not include chemotherapy * Age ≥ 60 years. * Life expectancy ≥ 1 year * Karnofsky Performance Score (KPS) ≥ 80 * Ability to understand and the willingness to sign a written informed consent document. * Healthy control subjects- Group 3 (control group) * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study: * Age ≥ 60 years. * Life expectancy ≥ 1 year * Karnofsky Performance Score (KPS) ≥ 80 * Ability to understand and the willingness to sign a written informed consent document. * Participants with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels \<250) may be included. * Serum Pregnancy Testing: STAT quantitative serum hCG pregnancy testing for all women of childbearing potential. Imaging will not start until and unless the test result returns negative.
Exclusion criteria
* Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study: * Participants with clinical or radiographic evidence of metastatic CNS disease * Subjects with MMSE scores below 24 * Active or history of major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with ECT (Mild depression that is well treated with stable dose of SSRI antidepressants may be allowed). * Substance abuse within the past 2 years * Huntington's disease, hydrocephalus or seizure disorder * In addition to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cognitive performance scores | Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between baseline amyloid accumulation in the brain and change in cognitive performance | Baseline, 6 months after completion of chemotherapy |
| Correlation between baseline tau accumulation in the brain and change in cognitive performance | Baseline, 6 months after completion of chemotherapy |
| Correlation between change in tau accumulation in the brain (from baseline to 6 months after completion of chemotherapy) and change in cognitive performance (from baseline to 6 months after completion of chemotherapy) | Baseline, 6 months after completion of chemotherapy |
Countries
United States
Contacts
CONTACTMichael W Parsons, PhD
PRINCIPAL_INVESTIGATORMichael Parsons, PhD
Massachusetts General Hospital
Outcome results
None listed